Trial Outcomes & Findings for Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis (NCT NCT01660243)
NCT ID: NCT01660243
Last Updated: 2022-02-09
Results Overview
The subject indicated the number on the line from left (0:no itching) to right (10:worst itch I have ever experienced). Assessments was made twice daily using an electronic Patient Reported Outcomes (ePRO) device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, at approximately 8 am and at approximately 8 pm. Subjects selected the number that best described the worst itch during the day (assessed at approximately 8 pm) or during the night (assessed at approximately 8 am). The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline (average over the Run-in Phase \[Days -7 to -1\]) score in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
TERMINATED
PHASE2
45 participants
2 weeks, 4 weeks and 8 week
2022-02-09
Participant Flow
Subjects who remained eligible entered the 1-week Run-in Phase. The NRS, VAS, and Itch Severity Score were averaged and formed the Baseline itch-intensity scores. After the Run-in, subjects who met additional inclusion criteria (having an NRS score for at least 5 days out of the 7 days and a mean worst NRS score ≥5) entered the Double-blind Treatment Phase (8 weeks) and were randomized to 1 of 4 study treatments.
Participant milestones
| Measure |
MT-9938 2.5μg
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
13
|
11
|
11
|
|
Overall Study
COMPLETED
|
8
|
13
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
MT-9938 2.5μg
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
0
|
|
Overall Study
Unable to visit clinic to obtain study drug due to hospitalization
|
1
|
0
|
0
|
0
|
|
Overall Study
Subject was noncompliant with study drug after experiencing AEs; was not discontinued due to the AEs
|
0
|
0
|
1
|
0
|
|
Overall Study
Randomization error
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis
Baseline characteristics by cohort
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
54.6 years
STANDARD_DEVIATION 12.78 • n=7 Participants
|
55.3 years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
55.2 years
STANDARD_DEVIATION 12.94 • n=4 Participants
|
55.8 years
STANDARD_DEVIATION 12.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weekPopulation: ITT
The subject indicated the number on the line from left (0:no itching) to right (10:worst itch I have ever experienced). Assessments was made twice daily using an electronic Patient Reported Outcomes (ePRO) device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, at approximately 8 am and at approximately 8 pm. Subjects selected the number that best described the worst itch during the day (assessed at approximately 8 pm) or during the night (assessed at approximately 8 am). The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline (average over the Run-in Phase \[Days -7 to -1\]) score in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS)
At 8 weeks (EOT)
|
-2.33 score on a scale
Standard Deviation 2.269
|
-3.13 score on a scale
Standard Deviation 2.833
|
-3.42 score on a scale
Standard Deviation 2.262
|
-3.39 score on a scale
Standard Deviation 3.614
|
|
Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS)
At 2 weeks
|
-1.11 score on a scale
Standard Deviation 1.224
|
-1.19 score on a scale
Standard Deviation 1.177
|
-1.12 score on a scale
Standard Deviation 0.828
|
-2.27 score on a scale
Standard Deviation 2.774
|
|
Change From Baseline in Worst-itching 11-point Numerical Rating Scale (NRS)
At 4 weeks
|
-1.41 score on a scale
Standard Deviation 2.032
|
-2.12 score on a scale
Standard Deviation 2.527
|
-1.85 score on a scale
Standard Deviation 1.392
|
-2.25 score on a scale
Standard Deviation 3.114
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weeksPopulation: ITT
The subject placed a single vertical mark on the line of a VAS corresponding to degree of itching intensity from left (no itching) to right (worst itch I have ever experienced). The VAS represents a 100 mm line. It consists of 101 selectable regions and the subject's score on the VAS will correspond to the region (0 to 100) selected on the line. Assessments was made twice daily using an ePRO device from the Screening Visit to the Follow-up Visit (Week 9). The 2 daily assessments was separated by 12 h, in the morning at approximately 8 am and in the night at approximately 8 pm. Subjects put a single vertical mark on the line to show the intensity of your worst itching during the day or during the night. The day or night score, whichever was greater, was used to calculate the weekly average score and changes from baseline in weekly average at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Worst-itching Visual Analog Scale (VAS)
At 2 weeks
|
-8.77 mm
Standard Deviation 15.158
|
-12.27 mm
Standard Deviation 12.154
|
-6.56 mm
Standard Deviation 18.778
|
-21.09 mm
Standard Deviation 26.719
|
|
Change From Baseline in Worst-itching Visual Analog Scale (VAS)
At 4 weeks
|
-14.17 mm
Standard Deviation 22.631
|
-19.46 mm
Standard Deviation 25.097
|
-21.24 mm
Standard Deviation 20.300
|
-23.63 mm
Standard Deviation 31.239
|
|
Change From Baseline in Worst-itching Visual Analog Scale (VAS)
At 8 weeks (EOT)
|
-23.06 mm
Standard Deviation 23.686
|
-29.16 mm
Standard Deviation 27.628
|
-24.49 mm
Standard Deviation 42.732
|
-30.09 mm
Standard Deviation 31.582
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weeksPopulation: ITT
The subject performed an assessment on day and nighttime symptoms of itch and effect of itch on sleep using a 5-point ordinal scale of itchiness (0 = none, 1 = mild, 2 = Moderate, 3=Severe, 4 = very severe). Assessments was made during each dialysis treatment (3x/week) and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9). Change from Baseline (average over the Run-in Phase \[Days -7 to -1\]) in Weekly Averages of Itch Severity Score were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Itch Severity Score
At 2 weeks
|
-0.77 score on a scale
Standard Deviation 0.721
|
-0.77 score on a scale
Standard Deviation 0.542
|
-0.43 score on a scale
Standard Deviation 0.872
|
-0.92 score on a scale
Standard Deviation 1.106
|
|
Change From Baseline in Itch Severity Score
At 4 weeks
|
-0.81 score on a scale
Standard Deviation 0.835
|
-1.08 score on a scale
Standard Deviation 0.741
|
-1.30 score on a scale
Standard Deviation 0.885
|
-0.90 score on a scale
Standard Deviation 1.275
|
|
Change From Baseline in Itch Severity Score
At 8 weeks (EOT)
|
-1.13 score on a scale
Standard Deviation 1.003
|
-1.49 score on a scale
Standard Deviation 0.919
|
-1.28 score on a scale
Standard Deviation 1.094
|
-1.28 score on a scale
Standard Deviation 1.197
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weeksPopulation: ITT
The PSQI has a minimum possible score of 0 (better sleep quality) and a maximum possible score of 10 (worse sleep quality). Subjects was asked to rate their sleep experience during the previous week. Pittsburgh Sleep Quality Index (PSQI) modified assessment was made during the dialysis treatment 1x/week every week and recorded on paper from the Screening Visit to the Follow-up Visit (Week 9).Change from Baseline (the Run-in Phase \[Days -7 to -1\]) were assessed and score at 2, 4 and 8 weeks as specified in the protocol are reported. Amount of change score of plus indicates worsening, and minus indicates improvement.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Change From Baseline in Sleep Quality Assessment
At 2 weeks
|
-0.4 score on a scale
Standard Deviation 1.06
|
-0.2 score on a scale
Standard Deviation 2.17
|
-0.2 score on a scale
Standard Deviation 1.64
|
-1.0 score on a scale
Standard Deviation 1.15
|
|
Change From Baseline in Sleep Quality Assessment
At 4 weeks
|
-0.4 score on a scale
Standard Deviation 1.92
|
-0.3 score on a scale
Standard Deviation 1.65
|
-1.1 score on a scale
Standard Deviation 1.36
|
-0.1 score on a scale
Standard Deviation 1.36
|
|
Change From Baseline in Sleep Quality Assessment
At 8 weeks (EOT)
|
-1.1 score on a scale
Standard Deviation 1.35
|
-0.6 score on a scale
Standard Deviation 1.62
|
-1.2 score on a scale
Standard Deviation 1.55
|
-0.4 score on a scale
Standard Deviation 1.59
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weeksPopulation: ITT
The Skindex-10 has a minimum possible score of 0 (itching not bothersome) and a maximum possible score of 60 (itching very bothersome). The Skindex-10 is a self-administered questionnaire used to evaluate the health-related QoL in UP. It is comprised of 10 questions, adopted for pruritus from the Skindex-16, a widely used instrument for a variety of skin disease. Subjects was asked to identify on paper at Baseline and Weeks 2, 4, and 8 (EOT) what has bothered them most during the past week by marking along a scale 0 to 6 boxes from "never bothered" to "always bothered. Change from Baseline (the Run-in Phase \[Days -7 to -1\]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Change From Baseline in QoL Assessment (Skindex-10)
At 2 weeks
|
-5.5 score on a scale
Standard Deviation 8.55
|
-11.6 score on a scale
Standard Deviation 11.16
|
-5.4 score on a scale
Standard Deviation 9.27
|
-13.6 score on a scale
Standard Deviation 15.21
|
|
Change From Baseline in QoL Assessment (Skindex-10)
At 4 weeks
|
-0.5 score on a scale
Standard Deviation 14.99
|
-16.5 score on a scale
Standard Deviation 15.00
|
-16.4 score on a scale
Standard Deviation 14.55
|
-13.7 score on a scale
Standard Deviation 17.68
|
|
Change From Baseline in QoL Assessment (Skindex-10)
At 8 weeks (EOT)
|
-11.9 score on a scale
Standard Deviation 5.61
|
-23.5 score on a scale
Standard Deviation 15.52
|
-19.2 score on a scale
Standard Deviation 14.59
|
-16.3 score on a scale
Standard Deviation 14.63
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weeksPopulation: ITT
The PGIC has a minimum possible score of 1 (very much improved) and a maximum possible score of 7 (very much worse). Subjects was asked to use a categorical scale with 7 categories to describe their global impression of change (PGIC) with study drug treatment. Subjects recorded their impression of change on paper at Weeks 2, 4, and 8 (EOT). Although the change from baseline (run-in phase \[Days -7 to -1\]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the mean value of patients at each point is shown instead.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change )
2 weeks
|
3.1 units on a scale
Standard Deviation 0.64
|
3.1 units on a scale
Standard Deviation 1.51
|
3.0 units on a scale
Standard Deviation 0.87
|
2.6 units on a scale
Standard Deviation 1.07
|
|
The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change )
4 weeks
|
3.3 units on a scale
Standard Deviation 0.71
|
2.8 units on a scale
Standard Deviation 1.36
|
2.5 units on a scale
Standard Deviation 0.93
|
2.8 units on a scale
Standard Deviation 1.09
|
|
The Mean Value in Treatment Satisfaction (Patient's Global Impression of Change )
8 weeks
|
2.6 units on a scale
Standard Deviation 0.98
|
1.9 units on a scale
Standard Deviation 0.90
|
2.1 units on a scale
Standard Deviation 1.17
|
2.2 units on a scale
Standard Deviation 1.30
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weeksPopulation: ITT
The 5-D-Itch scale has a minimum possible score of 5 (better) and a maximum possible score of 25 (worse). Subjects was asked to assess QoL by means of the 5D-Itch-Scale at Baseline, Weeks 2, 4, and 8 (EOT). The 5D-Itch Scale is a 5-item (duration, degree, direction, disability, and distribution) multidimensional measure of pruritus itch. Change from Baseline (the Run-in Phase \[Days -7 to -1\]) were assessed. Amount of change score of plus indicates worsening, and minus indicates improvement.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Change From Baseline in QoL Assessment (5-D-Itch Scale)
At 2 weeks
|
-2.8 score on a scale
Standard Deviation 2.12
|
-3.3 score on a scale
Standard Deviation 2.46
|
-3.0 score on a scale
Standard Deviation 2.62
|
-6.1 score on a scale
Standard Deviation 5.84
|
|
Change From Baseline in QoL Assessment (5-D-Itch Scale)
At 4 weeks
|
-1.6 score on a scale
Standard Deviation 4.17
|
-5.1 score on a scale
Standard Deviation 3.80
|
-5.6 score on a scale
Standard Deviation 3.16
|
-5.7 score on a scale
Standard Deviation 5.02
|
|
Change From Baseline in QoL Assessment (5-D-Itch Scale)
At 8 weeks
|
-3.7 score on a scale
Standard Deviation 3.90
|
-8.6 score on a scale
Standard Deviation 4.25
|
-6.2 score on a scale
Standard Deviation 5.01
|
-7.6 score on a scale
Standard Deviation 4.53
|
PRIMARY outcome
Timeframe: 2 weeks, 4 weeks and 8 weeksPopulation: Not all rows could be analyzed with the overall number analyzed due to several reasons (e.g. patient discontinuation, missing data etc.), so some rows have different number of subjects analyzed.
Investigator and/or the designated medically qualified staff assessed the subject's excoriation at Baseline, and weekly thereafter, by completing the subject's answers to the following questions: Excoriation present? Yes/No If yes, please rate the severity: Mild/Moderate/Severe Although the change from baseline (run-in phase \[Days -7 to -1\]) was specified as an outcome in this study, it was not calculated because the target enrollment was not met and no meaningful statistical analysis could be expected. Therefore, the number of patients at each point is shown instead.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
The Number of Patients in Excoriation
2 weeks · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
2 weeks · Excoriation not present
|
6 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
|
The Number of Patients in Excoriation
2 weeks · Mild
|
2 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
|
The Number of Patients in Excoriation
2 weeks · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
2 weeks · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
4 weeks · Excoriation not present
|
6 Participants
|
11 Participants
|
7 Participants
|
7 Participants
|
|
The Number of Patients in Excoriation
4 weeks · Mild
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Patients in Excoriation
4 weeks · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Patients in Excoriation
4 weeks · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
4 weeks · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
8 weeks · Excoriation not present
|
6 Participants
|
9 Participants
|
9 Participants
|
7 Participants
|
|
The Number of Patients in Excoriation
8 weeks · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Patients in Excoriation
8 weeks · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
8 weeks · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Patients in Excoriation
8 weeks · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
Baseline · Excoriation not present
|
7 Participants
|
6 Participants
|
7 Participants
|
7 Participants
|
|
The Number of Patients in Excoriation
Baseline · Mild
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
|
The Number of Patients in Excoriation
Baseline · Moderate
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
The Number of Patients in Excoriation
Baseline · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Patients in Excoriation
Baseline · Missing
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 weeksThe number of subjects with at least 1 treatment-emergent adverse event (TEAE). Please see the adverse event table for specific.
Outcome measures
| Measure |
MT-9938 2.5μg
n=10 Participants
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 Participants
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 Participants
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 Participants
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
|
6 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
Adverse Events
MT-9938 2.5μg
MT-9938 5μg
MT-9938 10μg
Placebo
Serious adverse events
| Measure |
MT-9938 2.5μg
n=10 participants at risk
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 participants at risk
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 participants at risk
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 participants at risk
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Infections and infestations
Diverticulitis
|
10.0%
1/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Metabolism and nutrition disorders
Fluid Overload
|
10.0%
1/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
10.0%
1/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
18.2%
2/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Gastrointestinal disorders
Pancreatitis Relapsing
|
10.0%
1/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
General disorders
Asthenia
|
0.00%
0/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
Other adverse events
| Measure |
MT-9938 2.5μg
n=10 participants at risk
Nalfurafine hydrochloride(MT-9938) 2.5μg: 2.5 μg (2capsules) once daily for 8 weeks
|
MT-9938 5μg
n=13 participants at risk
Nalfurafine hydrochloride(MT-9938) 5μg: 5 μg (2capsules) once daily for 8 weeks
|
MT-9938 10μg
n=11 participants at risk
Nalfurafine hydrochloride(MT-9938) 10μg: 10 μg (2capsules) once daily for 8 weeks
|
Placebo
n=11 participants at risk
Placebo: Placebo (2capsules) once daily for 8 weeks
|
|---|---|---|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
10.0%
1/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
7.7%
1/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
7.7%
1/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
45.5%
5/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
|
Gastrointestinal disorders
Nausea
|
10.0%
1/10 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
0.00%
0/13 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
27.3%
3/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
9.1%
1/11 • 8 weeks for treatment phase + 1 week follow-up visit after last dose
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The disclosure restriction on the PIs is that sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to sponsor for review. Sponsor can require changes to the communication which is considered confidential and/or proprietary. If necessary, sponsor shall have the right to request to delay the proposed disclosure for an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER